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Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

NCT05065528 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-29

No results posted yet for this study

Summary

This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

Conditions

  • Concussion, Mild
  • Traumatic Brain Injury, Mild

Interventions

DIETARY_SUPPLEMENT

Magnesium

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days

DRUG

Placebo

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill

Sponsors & Collaborators

  • Spectrum Health - Lakeland

    lead OTHER

Principal Investigators

  • Chris Trigger, DO · Spectrum Health - Lakeland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065528 on ClinicalTrials.gov